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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMAXUM SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplant, hearing, active, middle ear, partially implanted
ApplicantOTOTRONIX, LLC
PMA NumberP010023
Supplement NumberS006
Date Received09/15/2010
Decision Date11/05/2010
Product Code
MPV[ Registered Establishments with MPV ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new eo sterilization manufacturing site for the packaged implant assembly.
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